FDA OKs menthol e-cigs made by firm Altria recently bought, thus supporting its smoking-cessation claims; health advocates object

By Matthew Parrone
Associated Press

The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking.

Njoy menthol product

The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes.

The decision lends new credibility to vaping companies’ longstanding claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease. E-cigarettes have been sold in the U.S. since 2007 but in recent years their potential benefits for smokers have been overshadowed by their use by adolescents and teens.

Parents and anti-tobacco groups immediately criticized the decision, which follows years of advocacy efforts to keep menthol and other flavors that can appeal to teens off the market.

“This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children."

Youth vaping has declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year. Of those who vaped, 90% used flavors, including menthol.

In Kentucky polling in 2021, 45% of high-school students said they had used an electronic vapor product, 22% were current users, 8% were frequent users, and 7% used the products daily. Among Kentucky middle-school students, 24% said they had used an electronic vapor product, 11% said they were current users, nearly 3% said they were frequent users, and 2% said they used daily.

All the e-cigarettes previously authorized by the FDA have been tobacco, which isn't widely used by young people who vape.

Njoy is one of only three companies that previously received FDA's OK for vaping products. Two of the four FDA-approved products are "sealed, pre-filled, non-refillable pods that are used with a previously authorized Njoy device, and two are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir," reports Jessica Karins reports of Inside Health Policy.

Njoy’s products accounted for less than 3% of U.S. e-cigarette sales in the past year, according to Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon and blueberry ice.

Altria's data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed the products are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Friday’s action is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. The U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops.

The FDA faced a self-imposed court deadline at the end of this month to wrap up its yearslong review of major vaping brands, including Juul and Vuse.

Those brands have been sold in the U.S. for years, awaiting FDA action on their scientific applications. To stay on the market, companies must show that their e-cigarettes provide an overall health benefit for smokers, without significantly appealing to kids.

“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Matthew Farrelly of FDA’s Center for Tobacco Products.

Richmond-based Altria previously took a $13 billion stake in Juul in 2018, when the brand controlled most of the U.S. vaping market. But Juul's value plummeted after it was hit with lawsuits and investigations over its role in sparking a national spike in underage vaping.

Several longtime health-advocacy groups criticized the decision.

American Lung Association CEO Harold Wimmer wrote, “The tobacco industry has been using menthol and other flavors to attract kids for decades - this opens up a legal pathway for Njoy to market their highly addictive products.”

Lisa Lacasse, president of the American Cancer Society Cancer Action Network, noted that the move comes less than two months after the Biden adminisration announced an indefinite delay in FDA’s proposed rule to ban menthol cigarettes and flavored cigars, which had bene pending for two years.

"FDA has been more closely scrutinized by Congress over its e-cigarette regulation approach in recent months," Karins notes. "Lawmakers in both parties agree FDA isn’t doing enough to combat illegally imported e-cigarettes, but a partisan divide is emerging on whether the agency should respond by approving more domestic products. Some Republicans have suggested the agency should approve more applications for American companies’ products while Democrats largely want those products off the market as well."

In its announcement, "FDA appeared to respond to criticisms," Karins writes. Center for Tobacco Products Director Brian King said, “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.” 

King said Njoy submitted evidence "showing a benefit to adult smokers relative to the company’s previous tobacco-flavored products that is sufficient to outweigh risks of the products, including potential appeal to youth."

Karins notes, "FDA’s statement says authorization of the products does not mean they are safe, adding that people who do not use nicotine products shouldn’t start. It also says the agency remains concerned about youth vaping. It will monitor the marketing of the Njoy products levels of use of the products among youth and former smokers, and the number of smokers who are able to completely switch to the products."

Under the FDA rule, Njoy may not "use most advertising methods," and ads "cannot include cartoon images, images of food or fruit, or depictions of people who appear to be younger than 45," Karins reports. "Retailers must place Njoy products only in non-self-service areas of stores."

Comer and committee grill FDA chief about handling of vapes

U.S. Rep. James Comer, R-Ky.
(AP photo by Alex Brandon)

Kentucky Health News

Rep. James Comer of Kentucky and other House members "grilled FDA Commissioner Robert Califf about why the agency has failed to swiftly assess product applications for e-cigarettes while illicit products from China flood store shelves," Luke Zarzecki reports for Inside Health Policy. "Califf defended FDA's approach by saying the agency is not resourced to deal with the flood of millions of applications for vaping products."

Califf appeared Thursday at a hearing of the Comer-chaired House Committee on Oversight & Accountability that last almost five hours. "We covered topics from seafood inspection, all the way to every other topic that I think could be imaginable," Comer told Zoey Becker of FiercePharma.

"Multiple lawmakers blamed FDA’s failure to quickly approve e-cigarette and vaping products from the United States for the proliferation of illegal imports, Zarzecki reports, quoting Comer: “FDA’s failure to regulate has allowed unsafe and illicit products to proliferate.”

"Califf said FDA would be more equipped to deal with illicit products if Congress approved the agency’s request to require e-cigarette manufacturers to pay user fees," Zarzecki reports. "He said FDA will not approve applications for vaping products unless they demonstrate the product will not contribute to nicotine addiction among children and youth." He said no one expected 26 million applications, and FDA has requested more staff to address the backlog.

The agency has asked the Supreme Court to review an appeals court’s ruling that it consider every marketing application for flavored e-cigarette products individually, "rather than rejecting them en masse because of their impact on youth smoking," Zarzecki notes.

"Public health groups have also sued the FDA and HHS over delaying a ban on menthol cigarettes and flavored cigars, and a spokesperson for FDA noted the rule is pending at the White House Office of Management and Budget."

FDA Commissioner Robert Califf (AP photo)

Califf said that in 2023, FDA “issued warning letters to more than 120 manufacturers and distributors and more than 400 retailers; filed over 40 civil money penalty complaints against manufacturers and over 65 against retailers; and collaborated with our federal partners at the U.S. Customs and Border Protection to seize approximately 1.4 million units of unauthorized e-cigarette products with an estimated retail value of more than $18 million; among other actions.”

"Comer criticized FDA for not seizing more illegal products from retailers," Zarzecki reports, and said the agency's approach to e-cigarettes is not what Congress had in mind. Comer said, “Those seeking to play by the rules don’t even know what the rules are because FDA won’t tell them, or FDA won’t put information out, or they will put information out, but they change it.”

Califf said vaping and electronic cigarettes came along after Congress passed the Tiobacco Control Act, under which the FDA operates.

Comer, who represents the state's First Congressional Distict, also criticized FDA for “failing to do the bare minimum to carry out its core mission” under the Biden administration. He said “a pattern of issues” show the agency “appears consistently unprepared for crises.”

He noted that FDA inspections of foreign manufacturing plants, where many drugs sold in the U.S. are made, haven't returned to pre-pandemic levels. He said the agency inspected 79 percent fewer foreign plants in 2022 than it did in 2019.

Califf conceded, “We need to pick up the pace.” He said the FDA recently “completely" reworked its inspection system in India to address problems there. The agency is converting its Office of Regulatory Affairs into an Office of Inspections and Investigations, "reassigning some 1,500 staffers to related roles."

Bill is moving to create database (but not licensing) of vape retailers, raise fines and bring state law in line with FDA rules

A customer vapes at a shop in Richmond, Va. (Associated Press file photo by Steve Helber)

By Melissa Patrick
Kentucky Health News

A bill to create a statewide database of retailers that sell vaping products, and align state law with federal restrictions on the products, is moving through the Kentucky General Assembly.

House Bill 11, sponsored by Republican Rep. Rebecca Raymer of Morgantown, was approved with a committee substitute by the House Health Services Committee on March 7 and was posted for possible action by the House starting Monday, March 11. 

After nearly an hour of discussion, HB 11 was approved 14-1-3, with Rep. Felicia Rabourn, R-Pendleton (Henry County), voting no and Democratic Reps. Adrielle Camuel of Lexington, Rachel Roarx of Louisville and Lindsey Burke of Lexington passing. 

Rep. Rebecca Raymer

Raymer said she began working on the bill after learning that most items confiscated in Kentucky schools are flavored and disposable vapes,and “I found out that these vapes are not even supposed to be offered for sale,” under rules of the U.S. Food and Drug Administration.

She said opponents would say that the bill will all such products off the shelf, but “That is simply not true. There are other states that have used the same definitions that we are using. I think Alabama is one of the states and they have about 1,600 products on their registry of things that can still be sold.”

Raymer said Congress is lobbying the FDA to create a concise list of what is legal and not legal, and “We are not the regulatory authority over these products. We don't get to decide what is legal and illegal.”

Dr. Britt Anderson, a pediatric emergency-medicine physician and vice-president of the Kentucky Chapter of the American Academy of Pediatrics, told the committee that she sees children come into emergency rooms addicted to nicotine and unable to stop vaping, which makes them cough and wheeze and be unable to exercise.

Vaping has become much more common among Kentucky schoolchildren than smoking. While the long-term effects of vaping on young people's health are unknown, Anderson said what we do know about vaping and nicotine use in youth is not "cutting-edge science." 

"We do know that they cause lung injury and changes to brain development during a crucial stage of life," she said. "And it's not just the nicotine. The complete ingredient list may contain fine particles and other carrier solvents that are unhealthy as well."

Mallory Jones, a junior at George Rogers Clark High School in Winchester, told the legislators that high schoolers can easily purchase vaping products despite the age restrictions.

"Once one person in a friend group starts using e-cigarettes, word gets around of where you can buy these products illegally, and it spreads like a domino effect," she said.

Jones lauded the bill, saying, "Addressing the source of these products is critical to reducing youth access and initiation of nicotine, but the rules are only as good as the enforcement that we put behind them."

Griffin Nemeth, coordinator of the #iCANendthetrend Youth Advisory Board at the University of Kentucky, noted that while HB 11 does not allow Kentucky to join the 40 other states that have some form of comprehensive tobacco retail licensure, it does allow the state to have a better understanding of the retail environment.

But he added that alone is not enough to make a difference: "It is with, and only with, the three combined elements of a retailer database, compliance checks and stiff penalties for violations that we can implement comprehensive prevention at the point of sale." 

Opponents of the bill

Troy LeBlanc, a retailer and manufacturer of vape products, said he supports efforts to decrease youth use of them, but said this bill won't do that because the bulk of the products approved by the FDA are sold in convenience stores and that's where most of the bad actors are when it comes to selling these products to youth.

"I urge you to change this bill to put these products in 21-and-over stores and have them policed by the ABC and have them fined with major fines . . . Make sure that the fine hurts enough to where people will not do it," he said. 

LeBlanc also said this bill would eliminate access to low-nicotine products while allowing sale of high-nicotine products made by large companies. 

He said the average nicotine level of products sold in vape shops is 3 milligrams per milliliter, while the large companies like Altria (formerly Philip Morris), make products with a much higher nicotine content.

"I don't believe it's the right bill because all it's going to do is to make sure that Altria is the main seller in every convenience store . . . . Juul is going to be all over the state," he said. "Juul also does not offer any nicotine product that's lower than 30 milligrams per milliliter." 

LeBlanc also pushed back on Raymer's claim that Alabama allows 1,600 products on their shelves, saying that after dissecting the list, "There are only eight brands on there of flavored nicotine." 

Mike Reichert of Campbell County, who said he owns two vape shops in Northern Kentucky, said this bill would likely cause his shops to close. 

"Most of the products that I sell would be banned as this bill is currently written," he said. "It would almost certainly cause my stores to close." 

Reichert said he got into the business to help people quit smoking, making that possible by selling the lower-nicotine products that can be tapered down to zero nicotine in his store. He agreed with LeBlanc that sales should be limited to 21-and-older stores, with higher fines to keep the bad actors out. 

Tommy Wilson of Pulaski County, who said he owns two vape stores, also pushed for such a move, which he said would likely make this issue go away. 

Wilson said he had helped thousands of people get off nicotine via combustible cigarettes and move to a lower-dose vaping product. 

“We too don't want youth vaping," he said. "But that said, we feel like it’s an adult’s choice to be able to find something that they deem is less harmful to their body. . . . Is it perfect? Maybe not, but is it better than 3,000 chemicals and burning smoke going into your lungs? I feel it is." 

The committee chair, Rep. Kim Moser, R-Taylor Mill, asked the opponents of HB 11 to keep talking to the bill sponsor to see if any tweaks can be made. 

"No one wants to do anything that is going to put anyone out of business," she said. "That's not our goal." 

Legislators' concerns

Rep. Josh Bray, R-Mount Vernon, asked the vape-shop owners if they're selling products that are not FDA-approved, prompting them to walk through the history of vaping products in the U.S., the ongoing methodology challenges to get products approved by the FDA and the legal challenges surrounding this issue. 

Earlier in her remarks, Raymer noted that she understands that those in opposition of this bill don't like the FDA process for regulating these products, but the bottom line is that the FDA has that authority. 

"And so we, as a state, have an obligation to offer some protection to our citizens," she said. "If we know these products are not authorized, they are not legal per the FDA, we shouldn't have them."

Roarx, one of the Louisville Democrats, said she appreciates the bill’s goal to keep Kentucky youth away from nicotine products, but said she has concerns that the bill might have unintended consequences on the tobacco and e-cigarette industry by creating a monopoly.

“I hope we can continue to make progress to make sure that we’re not just giving a couple of brands a monopoly on the entire industry,” Roarx said. 

The bill would take effect Jan. 1, 2025. Among other things, it would:

• limit the sale of products to those authorized by the FDA and would punish retailers who sell unauthorized products to anyone under 21 years of age;
• require businesses that sell vaping products to acknowledge that in their annual business filings with the secretary of state;
• require the secretary of state to create a list of the businesses and share it monthly with the ABC and the state Department of Revenue;
• require the ABC to create and maintain a tobacco database and reporting system, to be published monthly;
• set rules around how manufacturers, wholesalers and retailers sell and distribute the products;
• establish fines for manufacturers, wholesalers and retailers for noncompliance; and
• allow police officers and ABC investigators to issue a uniform citation for any violation of the law. The citations would then be reported to and enforced by the ABC.

What are the fines? 

The bill would require any manufacturer of products covered by the federal Tobacco Control Act to sell authorized products to wholesalers and retailers. A manufacturer that violates this section would be subject to a fine of $25,000 for a first violation, $50,000 for a second violation and $75,000 for third and subsequent violations.

It would ban a wholesaler from selling unauthorized products and from selling authorized products to a retailer until it verifies that the retailer is not in the tobacco non-compliance database and reporting system. Violators would be subject to a $5,000 fine for the first violation, and $15,000 for the second and subsequent violations.

State law already bans sales to minors, with a fine of $100 to $500 for the first violation and $500 to $1,000 for the second violation. The bill would require the second-violation fine to be $1,000 and set a $5,000 fine for a third violation. A retailer with a fourth violation in two years would be banned from selling vapes. That would also apply to retailers who don't pay fines within 60 days.

At opioid panel's final hearing, Ben Chandler leads endorsers of funding research into psychedelic drug as treatment for addiction

By Melissa Patrick
Kentucky Health News

Twenty-three people spoke in favor of funding the development of an opioid-use disorder treatment using the psychedelic drug ibogaine with some of the state's opoid-settlement money at the Kentucky Opioid Abatement Advisory Commission's second and final public hearing on Friday, Sept. 15.

Ben Chandler (File photo)

Foundation for a Healthy Kentucky President and CEO Ben Chandler, a former Kentucky attorney general and five-term congressman, opened the meeting by saying that he had seen this problem from almost every angle.

Chandler spoke of a first cousin's addiction to opioids and other drugs and at least 15 failed attempts at recovery, having gone to "about every rehab center that you could go into of any note in this country." At age 30, the cousin "put a bullet to his head" and died. "He was like a brother to me."

Then his real remaining brother, Matthew Chandler, died of a fentanyl overdose in January. Ben Chandler said his brother sought illegal opioids to manage his pain because he wasn't able to legally obtain the pain medications he thought he needed, and he had been addicted to opioids for "probably 15 years." 

Chandler also talked about the surge of Oxycontin in Eastern Kentucky in the late 1990s, when he was attorney general, and his efforts to combat it, then about his time in Congress and the "enormous sums of money" spent to address this problem.  

"The bottom line to me is, despite the best efforts of so many people working on this problem for so many years -- and I mean that, they work their tails off, and they care deeply -- we have been unable, in my judgment, to solve this problem," he said. "It continues to be intractable, and we need as many tools as we can get.

"And I believe that a drug like ibogaine, from what I have read, it has the potential to make the difference that we need to have made, or at least a big difference. It's a tool that we can give the people who are working in the trenches, which will give them the opportunity, maybe, to break this cycle of addiction and actually save quite a number of lives. And I endorse anything that we can do to get that done." 

Most speakers and Opioid Abatement Advisory Commission staffers
at the Sept. 15 public hearing to discuss the psychedelic drug ibogaine
gathered for a group photo after the meeting. (Photo by Melissa Patrick)

Chandler said the proposed $42 million to fund this proposal, about 5 percent of the settlements with opioid makers and distributors, "is a drop in the bucket, compared to what has been spent over the years to try to deal with this problem. And spent quite frankly, to a large extent, unsuccessfully. We have successes, but we have a whole lot of failures. And I've seen those failures in my family, both my cousin and my brother, in and out of facilities, strong efforts to try to break the chain of addiction, both of them no longer with us." 

Ibogaine is illegal in the U.S. but has been anecdotally reported to stop the withdrawal symptoms of opioid dependence. The $42 million expenditure, to help get ibogaine federal approval in the next six years, was proposed by Bryan Hubbard, chair and executive director of the commission, which operates in the office of Attorney General Daniel Cameron, the Republican nominee for governor. 

Dr. Joseph Barsuglia, a clinical psychologist and ibogaine researcher who also provided a long list of professional connections to ibogaine, talked about the first time he witnessed an opioid detoxification with ibogaine in 2015. 

"I could not believe my eyes," he said. "To witness a patient with the most severe and chronic addiction you can imagine on death's doorstep undergo a 48-hour process and come out calm, connected, with a new radiance in their eyes and really wanting to live -- this is a miracle in the truest sense. With ibogaine, this is not a rare occurrence, this is the norm."

Barsuglia said ibogaine works for opioid-use disorder because it "rapidly alleviates opioid withdrawal and cravings and promotes lasting sobriety in a manner that is superior to opioid-maintenance therapies," and because "It induces dreamlike visions that increase insight into the causes of one's addiction, which can lead to durable psychological change." 

He said studies show that "ibogaine simultaneously targets addiction and craving to multiple substances, including alcohol, methamphetamines, cocaine and nicotine -- not just opioid use disorder," which is important because over half of opioid-use disorder patients are addicted to multiple substances.

Also, he said ibogaine is "fast acting and has durable outcomes." He said it takes 12 months to break opioid dependence with methadone and 12 hours with ibogaine. He added, "It reduces anxiety, improves mood, does not require ongoing burden on the medical system and has little potential for abuse."

The major objection to legalizing ibogaine are its risks to the heart. Barsuglia said that can be mitigated under a carefully controlled environment.

"I believe funding ibogaine research for opioid use disorder is perhaps one of the most obvious and necessary decisions that can be made in the history of addiction medicine," he said. 

Several speakers gave personal testimonies about their experience with ibogaine, with a recurring message that it not only healed them physically, but also spiritually.

Paria Zandi, a licensed marriage and family therapist in California, said she describes her life as two distinct chapters, "pre-ibogaine and post-ibogaine," and has been free of her opioid addiction for 10 years. 

"Through an intense 24-hour treatment, I emerged feeling reborn," she said. "Not only did I escape the clutches of the physical withdrawal symptoms and cravings, but I also began to relive some of the traumas in my life and gained a newfound perspective. I saw myself as someone of immeasurable worth, and a child of God. I experienced a profound sense of aliveness and connectedness that had eluded me until that moment." 

Zandi added that ibogaine is not a "cure-all" and if it is ever approved will need to be combined with social services, support systems and education. "We urgently need innovative approaches to addiction treatment, such as ibogaine," she said. 

Navy SEAL veteran and ibogaine patient Tommy Aceto told the commisison, "It wasn't just a medicinal treatment. It was a deep dive into my subconscious, self-forgiveness and most importantly, self-love."

Reed Madison, a parent of an ibogaine patient, said of his son, "The reason he went to an ibogaine clinic is because ibogaine offered him a solution for addiction interruption without withdrawals. . . . So I feel incredibly lucky that I learned about ibogaine at the time to help give my son a way out of his addiction problem before it was too late. I think there's a pretty good chance he may not be alive today had ibogaine not been available to him." 

In closing, retired Marine Corps Lt. Gen. Martin Steele, CEO of Reason for Hope and the president of the Veterans Mental Health Leadership Coalition, called on the commission to vote unanimously to fund the ibogaine initiative. 

"Our nation owes its citizens a viable alternative to something that's not working. You have it here in Kentucky, you have this moment in history, this moment in time," he said. "To conclude, I implore each and every member of the commission to support this initiative. A unanimous vote will send a message that will resonate loudly, nationwide."

Asked what was next, Hubbard told Kentucky Health News, "I think every commission member needs to take a little while to think over everything that they have heard. It's a tremendous amount of information to absorb that's been presented between May 31 and now we sit here on Sept. 15. And I think after some due diligence individually and collectively at some point, within some months, we'll be ready to put a vote on the agenda."

First drug to slow Alzheimer's disease gets full FDA and Medicare approval for early-stage cases; drug is still in clinical trials at UK

Dr. Jim Jackson of Morehead receives a lecanemab infusion
at UK's Sanders-Brown Center on Aging. (UK file photo) 

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration has granted full approval for the first drug to slow down the progression of Alzheimer's disease, opening the door for Medicare to pay for it.

"This is the first medicine ever that actually changes the disease in the brain, removes a component of the disease and can extend quality of life for patients who are developing and who are in the early stages of Alzheimer’s disease," Dr. Greg Jicha, director of clinical trials at the University of Kentucky Sanders-Brown Center on Aging, said at a news conference on Friday. 

Jicha stressed that the drug is not a cure, but instead has been shown in clinical trials to slow the disease process by 27% to 40%. 

Lecanemab, marketed by Japanese drug maker Eisai and U.S. partner Biogen under the brand Leqembi, is an antibody that targets amyloid plaques, which are found in brains of people with Alzheimer's. It is administered twice a month, intravenously; the firms have estimated treatment will cost $26,500 a year. 

The drug has been on the market since January 2023 under an accelerated approval from the FDA but was not broadly covered by Medicare. Following the FDA's full approval of the drug, Medicare, which primarily serves adults age 65 and older, will now cover it for those who qualify. 

With the Centers for Medicare and Medicaid Services' announcement, Jicha said the approval would make coverage more likely by other insurers, including Medicaid, which is a federal-state program.

Jicha also said he hopes Esail will have patient-assistance programs to ensure that anyone who qualifies for the drug has access to it. 

“I really think it behooves all of us to ensure that this medicine is accessible to everybody,” he said. “No matter what their socioeconomic status, no matter what their geographic limitations are, everyone who has early Alzheimer’s disease deserves the opportunity as long as the medicine is going to be safe for them.”

Dr. Jim Jackson, a retired pediatrician from Morehead, participated in an 18-month lecanemab study at UK and is now part of what his wife, Sharon, called an "extension study." 

"I felt that it was really a good opportunity to be part of something that can improve life for many, many people," he said at the news conference. Later adding, "I would be very happy to recommend this drug. I've been tickled to death to be in the study." 

Jicha said there are some side effects to the drug, including amyloid-relating imaging abnormalities (ARIA), typically a temporary swelling and/or bleeding in certain areas of the brain that usually resolve over time. He said people with two copies of a well-known Alzheimer's risk gene may be more at risk of ARIA. 

Sharon Jackson said her husband has responded well to the drug and has had no side effects. When he started the clinical trial, she said, "Jim had a little bit of memory issues and I can plausibly say that it has not progressed very much. . . . I can see that this medication, from what I understand about Alzheimer's, seems to be holding him pretty steady."

Who qualifies for the drug?

The medication will only be available to those in the early stages of the disease, and doctors willhave to verify that there is a buildup of amyloid in the brain before they can prescribe, Jicha said. Also, he said the drug must be administered by specialists who understand how to provide the treatment and to monitor for safety. 

“This medicine is only for those with mild memory problems, what we call mild cognitive impairment or folks that are in the mild stage of Alzheimer’s,” Jicha said, because benefits are uncertain for those in “a more moderate or severe stage.”

The drug is not available to people at risk of Alzheimer's, but Jicha said ongoing clinical trials are evaluating the usefulness of the drug for this group.   

The Alzheimer's Association promoted early detection and diagnosis in its press release celebrating the full approval of lecanemab. 

"With this approval, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible. If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis and to discuss treatment options," says the release. 

In Kentucky, 75,000 people 65 and older are living with Alzheimer's and that number is expected to increase by 15% in the next few years, to 86,000 in 2025, according to the Alzheimer's Association. Further, the association says 11.2% of people aged 45 and older have subjective cognitive decline.

Some people have misgivings. "Providers and health researchers who have doubts about the drug’s safety and efficacy say the decision exemplifies broader problems with FDA’s approval process," Jessica Karins of Inside Health Policy reports. "The critics raise concerns with the safety profile of the early-stage Alzheimer’s treatment . . . and say the difficulty of measuring cognitive decline means it remains unclear how much the drug can slow the progression of Alzheimer’s disease."

FDA panel recommends updating Covid-19 vaccines; here's why

The Food and Drug Administration's external scientific committee unanimously recommended Thursday that Covid-19 vaccines be updated to thwart new versions of the virus, which is mutating about twice as fast as the flu, vaccines for which are updated annually, Katelyn Jetelina reports in Your Local Epidemiologist.

Also, "The current Omicron variant (XBB) circulating is meaningfully different than other Omicron variants," Jetelina writes. "Covid-19 vaccines are waning in protection against hospitalization (62% effectiveness has dropped to 24%) and ICU admission, albeit with a smaller decline (69% to 52%). This is happening faster when exposed to XBB virus compared to other Omicron variants."

Hospitals aren't filling up with Covid patients "because vaccine effectiveness now represents the incremental benefit above and beyond the baseline protection in the general population. This is different than when we first introduced vaccines and the general population had a very low immunity wall." In other words, natural immuiity (not just antibodies but other features of the immune system) combined with vaccines provide a relatively high immunity wall.

What's next? "Pfizer, Moderna, and Novavax will start manufacturing millions of vaccines. Once they’re ready, the FDA will approve the updated vaccine," Jeteline writes. Then the committee "will determine who should get the vaccines. Expect this to happen in late summer or early fall."

"Everyone’s curious to see how this year plays out," Jetelina says of her community of interest. "The rest of the year will be very telling as to whether Covid-19 has settled into a seasonal, predictable pattern. Comparing Covid-19 to the flu is helpful, but the viruses, and thus processes, are different. This needs to be communicated better."

She adds, "Don’t let anyone tell you there are no human data on these vaccines. All vaccine manufacturers presented preliminary data on humans and animals. What we do not have yet is the safety of these vaccines when combined with RSV and flu vaccines." RSV is respiratory syncytial virus, which targets mainly the young and the elderly. 

FDA proposes new requirements for makers of tobacco products aimed at minimizing contamination, protecting public health

American Heart Association photo illustration

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration is proposing new rules that are aimed at minimizing contamination of tobacco products, including electronic cigarettes, and that would create manufacturing specifications to ensure product consistency. 

“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” Brian King, director of the FDA’s Center for Tobacco Products, said in a news release. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

The proposed regulations aim to see that tobacco products are made according to established specifications and would require manufacturers to take appropriate measures to prevent contamination of the product. 

One regulation says companies that create products that don't meet those specifications will be investigated and be required to institute appropriate corrective actions, such as a recall. 

Another establishes the ability to trace all components or parts, ingredients, additives and materials, including by batch of the finished product, to aid in such investigations. 

"These requirements would help minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products," FDA said in its release. "The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids; such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins."

"The FDA says there have been inconsistencies between what’s in e-cigarettes and what’s on the label," CNN reports. Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told CNN he was disappointed by the timing of the proposed rule.

“The vaping industry has tried in vain for more than a decade to work with FDA on sensible manufacturing standards, only to be ignored while the agency recklessly vilified nicotine vaping,” Conley told CNN in an email. “It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market. The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal, but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”

The FDA will hold a public hearing April 12 about the proposed rule. 

CDC: Only 5 Ky. counties have high risk from coronavirus; FDA panel recommends one annual Covid-19 vaccination for everyone

Centers for Disease Control and Prevention map

By Melissa Patrick
Kentucky Health News

Only five Kentucky counties, all but one along the Virginia border, have a high level of Covid-19 risk, according to the latest weekly map from the Centers for Disease Control and Prevention. The map showed only slight shifts among medium-risk and low-risk counties.  

Gov. Andy Beshear noted at his weekly news conference, held before the CDC report was released, that new corinavirus cases in Kentucky continue to move up and down a bit, continuing the recent plateau, but the recent increase in Covid-19 hospitalizations is subsiding. 

Again, he made a plea for Kentuckians to get the new Covid-19 booster shot and encouraged Kentuckians to make "wise decisions" when it comes to other preventive measures, like masking. 

"You know, masking when you choose to is a safe and effective tool," he said. "So please consider it when you believe that you need it." 

The CDC map, which is based on Covid-19 cases and hospital numbers to determine transmission and risk, shows number of high risk counties, shown in orange, dropped 54.5 percent from the prior week when the state had 11 counties in this category. 

All the high-risk counties continue to be in the eastern part of the state: Wolfe, Pike, Letcher, Harlan and Bell counties. 

In high-risk counties, the CDC continues to recommend that you wear a well-fitting, high-quality mask in public indoor spaces, and if you are at high risk of getting very sick, consider avoiding non-essential indoor activities in public where you could be exposed.

The map shows 49 Kentucky counties at medium risk, shown in yellow; and 66 at low risk, gown in green. 

If you live in a medium or high-risk county, the CDC advises those who are at high risk of getting very sick to wear a well-fitting mask when indoors and in public and to consider getting tested before having social contact with someone at high risk for getting very sick and consider wearing a mask when indoors when you are with them.

Centers for Disease Control and Prevention map

The CDC also has a transmission-level map, largely used by researchers and health-care facilities, that shows the level of virus spread in each county, at one of four levels. For the first time in a while, it shows one county with a low level of transmission: Todd. Twenty-six counties had with a moderate level of transmission, up from 15 in the prior week, and the rest had either substantial or high levels of transmission.

State officials have encouraged Kentuckians to use the other CDC map to guide their preventive measures.

On Thursday, Jan. 26, a U.S. Food and Drug Administration advisory panel voted unanimously Jan. 26 in favor of moving to an annual Covid-19 vaccine made up of one formula, with every person getting the same vaccine whether they are already vaccinated or not.

Dr. Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine in Texas, "said he prefers a twice-a-year routine to account for the anticipated summer and winter surges each year," The Houston Chronicle reports.

“What they're really doing is balancing the science that says, ideally, semi-annually, with the reality that Americans are not really accepting the boosters barely anyway,” Hotez said. But Pfizer and Moderna "are considering raising the price of a single vaccine dose to $130, and the Biden administration has said it no longer has the Covid-19 funding to make additional purchases," the Chronicle notes.

Meanwhile, a committee of the World Health Organization began meeting Jan. 27, to discuss recommending that the agency declare Covid-19 is no longer a major global health emergency. The WHO said no recommendations would be issued before Monday.

FDA OKs Alzheimer's drug, which may not be available soon, and carries some risks; UK testing on patients with marker of disease

Medscape photo

Kentucky Health News

The U.S. Food and Drug Administration has approved a drug that has been found to help people in the early stages of Alzheimer's disease and is being studied at the University of Kentucky.

Lecanemab, to be marketed as Leqembi, has been approved through an accelerated approval process. It is to be used for Alzheimer's patients who have mild cognitive impairment or are in the mild dementia stage of the disease, the population that was studied in clinical trials -- which showed the treatment effectively removed amyloid beta plaque, a key marker of Alzheimer's disease, from the brain. The phase 3 trial, of nearly 1,800 people with early Alzheimer's and evidence of amyloid, found that those who got lecanemab for 18 months had a 27% slower cognitive decline than those who got a placebo.

"Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease," the study authors reported in The New England Journal of Medicine, noting some "adverse events." The Columbus Dispatch reports that after the study concluded, two patients who remained on the drug died, both were on blood thinners. Marrwan Sabbagh, a neurologist and Barrow Neurological Institute researcher who analyzed the safety of lecanemab on behalf of its manufacturer, told the Dispatch that the deaths of patients on blood thinners "continue to be explored" and that such patients "might need some further consideration."

The Dispatch also noted that the FDA approval came two days after researchers detailed a death possibly linked to the drug. Despite the risks, the Dispatch reports, "Sharon Cohen, a neurologist and director of the Toronto Memory Program, said patients might be willing to accept the drug's risks for benefits such as recognizing loved ones, staying active, or performing everyday tasks."

UPDATE, Jan. 14: The trial found brain swelling and hemorrhage, respectively, in nearly 13% and 17% of the patients who received lecanemab, and only 2% and 9% of the placebo group, National Geographic reports: "Of the patients who took the drug and experienced brain swelling and hemorrhage, roughly 3% developed symptoms like headache, dizziness, and confusion. The others exhibited no symptoms, despite the swelling and bleeding. Matthew Schrag, a neurologist at Vanderbilt University, told National Geographic that could suggest that taking lecanemab is largely safe, “but we don’t know that.”

The Japanese drug firm Eisai, which developed lecanemab in partnership with Biogen, said in a news release that it will price the treatment at $26,500 per year for bi-weekly doses. The Wall Street Journal reports that lecanemab will be out of reach for most U.S. patients in the coming months because Medicare will only pay for this type of Alzheimer's drug for patients enrolled in a "government-sanctioned clinical trial, and no such studies are ongoing or planned." The Alzheimer's Association patient-advocacy group has asked the Centers for Medicare and Medicaid Services to reconsider its policy. 

UK study

Researchers at the University of Kentucky are researching lecanemab to see how it works on people who have no cognitive symptoms of Alzheimer's disease but have the amyloid protein that forms plaques that disrupt brain function, called "preclinical AD."

UK says the study is the first Alzheimer's disease trial to recruit people as young as 55 who are at risk of developing symptoms of the disease as they get older.

The trial still needs study participants and researchers want to make sure the opportunity is available to a wide range of the population.

“We especially want to reach out to those that have experienced health care discrimination,” said one researcher, Dr. Greg Jicha. “If you live in a rural area or are a person of color, you should know that we value you as much as we do everyone else. An effort this important needs to be available to everyone.”

To learn more about the study, call 1-800-AHEAD-70 or to find a trial site location enrolling near you, visit www.AHEADstudy.org. Learn more about enrolling in aging studies at UK's Sanders-Brown Center on Aging here.

UPDATE, Jan. 16: For a Q and A about the drug, click here.

FDA chief, at UK, says 'It's fair to be critical' of failure to control e-cigarettes; voices concern about life expectancy, misinformation

By Melissa Patrick
Kentucky Health News

U.S. Food and Drug Administration Commissioner Dr. Robert Califf said Friday at the University of Kentucky, "It's fair to be critical of the FDA" regarding the agency's struggle to regulate electronic cigarettes.

Asked in a news-media interview what the FDA is doing to crack down on e-cigarette companies that defy FDA rules and continue to sell their products, with reports that the FDA is not enforcing the law to shut them down, Califf replied that this is a "tough issue." 

Robert Califf, M.D.

Califf said that while federal law requires the companies to submit an application to the FDA to determine if they can stay on the market, it turns out that there are 6.7 million vape products, which "no one expected." He said there were already a million synthetic nicotine products on store shelves by the time Congress passed a law to cover them.

"It's been a lot more labor-intensive than was expected," he said. "We're doing a complete evaluation now that will be out in December and enforcement is a big part of that. And I would just say, it's fair to be critical of the FDA in this regard.

"But in order for FDA to have enforcement, like taking things off the shelves, that involves other branches of government also. And so we've got to figure out how to adapt to a much more creative industry than we expected in terms of all the products that are developing and the way they're dealing with it." 

As a guest speaker at UK Healthcare's 60th Anniversary Symposium, Califf touched on a number of health-related topics very relevant to Kentucky, including tobacco use, decreasing life expectancies and the role of health-related misinformation.

He said Kentucky still has work to do on tobacco use, since it still has one of the top rates in the country (21.4% of adults) and is likely to lose about 8,000 people this year to tobacco-related illnesses.

"So we've got to work together to help people stop using tobacco or reduce their use of tobacco . . . and underneath that, we've got vaping, which is rising while the use of tobacco is declining," Califf said in the interview. "Those things are right in the core mission of the FDA." 

The FDA is working on a proposal to remove menthol from tobacco products to discourage smoking. The move has been long in coming because menthol cigarettes are the choice of most Black smokers. 

"Get rid of that and you're pretty much left with tobacco-flavored tobacco," he said. "That's going to, I think, be a disincentive for people to continue to use it. . . . Law prohibits us from eliminating tobacco products, you can't take them completely off the market."  

Life expectancy: Califf voiced grave concern that life expectancy, the most basic measure of population health, has decreased in the U.S. during the pandemic and is five years shorter than the average of other high-income countries. He pointed out that life expectancy is lower in the Appalachian region and the Southeast. 

"We've got very significant work to do if we're going to turn this around," he said, adding later, "It's something that I believe is an emergency that we need to take seriously, and it's something that is not sustainable."  

One of the ways to improve life expectancy, he said, is to improve health outcomes, which include things that we already know how to treat like obesity, low physical activity, cigarette smoking, high blood pressure and diabetes -- all conditions that plague Kentuckians. He also noted the widening disparities in health outcomes in rural people, compared to urban ones. 

"These are things that are not foreign objects to us, we understand them reasonably well," he said. "We're just not doing a good job of executing on the things that we already know."

He later told reporters that experts say it will be important to fix the underlying social determinants that impact health if we are ever going to move the needle on health outcomes, including things like fundamental economic and income distribution and the education system. 

"The good news for our health is, poor people can have really good health because you are talking about blood pressure, cholesterol level, use of tobacco, simple screening things that aren't very expensive. The most important drugs now are generic . . . so this is why I keep gravitating back to having a primary-care system that works." 

The role of the FDA in all of this would be in the regulation of food and nutrition and tobacco and digital products that would enhance better health outcomes, he said. 

He touched briefly on the increasing number of deaths caused by substance-use disorders, but did say that there is a great need for a non-addictive treatment for pain, which we don't have yet. 

Misinformation: Califf spent a fair amount of time talking about health misinformation, which he defined as when well-intentioned people get health information wrong and then influence a lot of people by sharing that bad information. He said it is largely driven by the widespread use of social media and the internet.

"I can't find a single expert who can put credibly put forth a strategy that will turn around the fact that we're losing the battle on misinformation right now," he said. 

Califf called on state health institutions and health professionals to actively work to dispel misinformation, most recently as it relates to the Covid-19 vaccinations and boosters. 

"We know that the most effective way to counter misinformation is through human interpersonal interaction with someone that you trust," he said "If we don't build this in as an active part of our medical education, what our doctors and nurses and pharmacists to in day to day work, we're going to lose." 

As for the FDA's role, Califf said one of the agency's missions is to provide people with reliable information about products, and the FDA will continue to put out reliable information. 

"We have a responsibility to try to do something about it, but it's overwhelming," said Califf, who is serving in his role as FDA commissioner for the second time. "The government can't fix this because there's so much mistrust of government that we need the private sector to pitch in. And we need the press to pitch in and be aware of when it's promoting misinformation and things that will affect people's health in a negative way." 

FDA OKs updated Covid-19 booster targeting latest Omicron subvariants; Beshear says it could be available in Ky. next week

medpagetoday.com photo

By Melissa Patrick
Kentucky Health News

The new, updated Covid-19 booster shots that target the original strain of the coronavirus and major Omicron subvariants could be available to Kentuckians as early as next week, Gov. Andy Beshear said Wednesday.

The Food and Drug Administration authorized the updated booster shots from Moderna and Pfizer-BioNTech on Wednesday, Aug. 31. They are called bivalent Covid-19 vaccines because they have two major targets.

“The Covid-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of Covid-19,” FDA Commissioner Robert M. Califf said in a news release. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent Covid-19 vaccine to provide better protection against currently circulating variants.”

Omicron variants are responsible for nearly all current Covid-19 cases in Kentucky and are expected to circulate throughout the fall and winter. The FDA says the updated boosters are designed to provide broad protection against Covid-19 and even better protection against the currently circulating Omicron variants.

The new vaccine arrives at a time when Covid-19 "continues to spread across Kentucky," Beshear said at his weekly news conference. This week's state report showed an increase in all of the metrics used to measure the impact of the coronavirus in the state, with new cases up 15.6%, to 14,312, an increase of cases among school-aged children and a positivity rate -- which does not include at-home tests- over 20%. 

"We continue to recommend that everyone six months of age or older stay up to date on their vaccinations and receive any booster doses," said Beshear. 

So far, state data shows that fewer than half (46.6%) of the 2.6 million fully vaccinated Kentuckians have been boosted. 

The updated booster shots will become available after they are recommended by the Centers for Disease Control and Prevention, which is scheduled to vote Thursday. Then, the CDC director must sign off on the recommendation. 

The updated Moderna booster is authorized for use in individuals 18 years of age and older if it has been at least two months since they completed their primary vaccination or have received the most recent booster dose. 

The updated Pfizer booster is authorized for use in individuals 12 years of age and older if it has been at least two months since they have completed their primary vaccination  or have received the most recent booster dose, according to the FDA.

The FDA no longer authorizes the original boosters for administration to those 12 and older, but does authorize it for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer Covid-19 vaccine, says the release. 

Further, the FDA says, "You are eligible for an updated Covid-19 vaccine booster, the updated booster you receive does not need to be from the same manufacturer that made the vaccine you received for your primary vaccination or previous booster." 

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release, “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent Covid-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency-use authorization.”

FDA has authority to crack down on illicit vapes, but isn't doing it, Stat reveals; study finds increased e-cig use among lesbian girls

Food and Drug Administration photo

Even though the U.S. Food and Drug Administration has ordered hundreds of flavored, nicotine-heavy vaping products off of the market, "a Stat investigation found that vape companies are regularly flouting the FDA’s orders. They’re making, stocking, and selling the illicit goods. And the agency is just letting it happen," Nicholas Florko and Elissa Welle report for Stat, the medicine-and-science publication of The Boston Globe.  

The authors write that while the FDA has ordered more than 100 vape manufacturers to stop making more than 250 specific flavors and vapes, "We found scores of companies across the country that are defying the FDA's demands." 

And despite having "sweeping legal authorities" to crack down on vape companies that ignore its bans, "ranging from levying seven-figure fines to physically pulling products off shelves," the Stat investigation found that the FDA has never used those powers, according to its own data. And in several cases, "It’s even dropped cases against companies that it knows are still selling illegal products," Florko and Welle write. 

The authors note that the FDA declined Stat’s request for an interview with FDA Commissioner Robert Califf or the head of the FDA’s Center for Tobacco Products, Brian King, but say a spokesperson implied the agency may soon get tougher against companies that ignore its orders,

“The agency is currently working on further enforcement in situations where companies that have [been banned from the market] continue to sell illegal products,” the spokesperson told Stat in an email. “The FDA is currently engaged in discussions with the Department of Justice regarding specific potential enforcement actions.”

Vape shops argued that the FDA’s orders aren’t clear enough, and that until they are more so, they'll keep selling the products.

The shops “are doing their best, despite a complete lack of clarity or transparency from the agency, to piece together what products are still legally able to be sold,” Amanda Wheeler, president of American Vapor Manufacturers, told Stat. “It would be legally and morally irresponsible for us to recommend that companies should voluntarily close down their businesses because FDA cannot sort out their filing systems.”

The authors walk through the FDA's regulation process for vaping products that ultimately requires every company that manufactures a vaping product to get the FDA's permission before selling their products in the United States. After being pushed back from November 2018, the deadline for asking permission was September 2020. And last year, the FDA finally started denying some companies' requests to sell their vaping products, resulting in many companies ignoring the requests. 

As part of the investigation, "Stat reviewed 120 letters issued to vaping companies between August 2021 and May 2022, covering bans on some 274 named products. According to company websites and information provided by vape shops by phone, at least 139 of the products are still being sold — more than 50% of the products named in those warnings." 

“If a large portion of the vaping products FDA has ordered off the market are still being sold, I’m baffled," Bill Schultz, a former deputy FDA commissioner who also served as the federal health department’s top lawyer and represents the Campaign for Tobacco Free Kids, told Stat.  “Congress gave the agency the authority to act decisively and they should be using it.”

The authors note that their investigation is likely an underestimation of the issue, since they only analyzed warning letters sent to companies that formally asked the agency for permission to sell their products, and then had that request denied and did not focus on the hundreds more companies that received warning letters for never asking the FDA for permission at all.

Much of the impetus for the FDA  to crack down on vaping companies' sale of products came from the surge in teenagers' use of these highly addictive devices. From 2019 to 2020, the popularity of disposable electronic-cigarette use among U.S. high school students who currently vaped went up by 1,000 percent, from 2.4% to 26.5%, according to the Centers for Disease Control and Prevention. 

Researchers are beginning to look at which groups of teens vape and the underlying reasons that put them at risk to start with. 

One such study recently published in the American Journal of Preventive Medicine, looked at the prevalence of vaping among high-school students in different sexual orientation, race and ethnicity groups. The study used survey data from more than 38,000 U.S. high-school students from 2015-2019.

The study uncovered significant differences in the prevalence of current electronic-cigarette use between lesbian and heterosexual girls when comparing across racial groups, says a news release from the Annenberg School for Communication at the University of Pennsylvania.  

"Current e-cigarette use was higher in Black girls who identify as lesbian compared to Black girls who identify as heterosexual (18.2% versus 7.1%)." the release says. "The rate was also higher in multiracial girls who identify as lesbian compared to multiracial girls who identify as heterosexual (17.9% versus 11.9%). On the other hand, white girls who identify as lesbian were found to be at lower risk of current vaping compared to white girls who identify as heterosexual (9.1% versus 16.1%)."

The study found that among boys, there were no significant interactions between sexual orientation and race or ethnicity in relation to vaping prevalence.

The authors note, "Previous surveys of gay and lesbian teens suggest that e-cigarette use might be a coping mechanism to deal with the stress of sexual orientation or gender identity-based discrimination or bullying — or a way to bond with others in their social circle." 

They also suggest that a possible reason for finding disparities in e-cig use at the intersection of sexual orientation and race among girls — but not among boys — may be due to higher levels of targeted e-cig marketing toward lesbians of color. 

“For years, the tobacco industry has targeted marketing toward traditionally marginalized groups, whether in clubs, bars, Pride events, or through magazines,” Andy Tan, co-author of the study, said in the release. “Sexual, racial, and ethnic minority youth are more likely to report engaging with online tobacco advertising including e-cigarette ads on social media.”

FDA orders Juul products off the shelves, and firm asks court to block it; rule to limit level of nicotine in cigarettes is coming

Photo from Juul Labs

UPDATE, June 27: A federal judge blocked the order pending proceedings in Juul's lawsuit.

By Melissa Patrick
Kentucky Health News

The federal government has ordered Juul Labs to stop selling and distributing its products in the United States after denying the company's application to keep selling them, saying the company did not provide adequate data to determine "relevant health risks." 

Meanwhile, the Food and Drug Administration is planning to establish a maximum nicotine level in cigarettes and other combustible tobacco products to reduce the addictiveness of the products, which claim the lives of 480,000 Americans each year, with more than 8,000 in Kentucky.

"While we welcome the ban on Juul -- we think that's a good thing -- it is not nearly enough, and until they actually come to grips with the nicotine problem, they're not going to solve this," said Ben Chandler, president of the Foundation for a Healthy Kentucky. "The central problem here is that we are addicting an entire new generation of young people to nicotine."

The FDA issued marketing denial orders against Juul that require the company to remove its electronic-cigarette products from the U.S. market, or risk enforcement action. 

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in the release. He also noted the role of e-cigarettes in the rise of youth vaping.

The 2020 National Youth Tobacco Survey found Juul was the most popular e-cigarette brand used by adolescents with 25.4% of high school e-cigarette users and 35.1% of middle school users saying Juul was their most used brand.

According to the latest 2019 Youth Risk Behavior Surveillance System report, 26% of Kentucky's high school students had used an electronic vapor product on at least one day in the 30 days prior to the survey, while just 8.9% had smoked cigarettes. A national survey found youth vaping rates have declined during the pandemic, but a separate survey taken in late 2020 found that 34% of the 400 Kentucky youth surveyed believed there had been an increase in tobacco use due to the pandemic.

The FDA said the company's marketing applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” 

A key public-health issue the FDA looks for in reviewing electronic cigarettes is whether the potential benefit to adult smokers who may be using them to quit smoking is greater than the risks to youth. 

The agency said it didn't see clinical information suggesting there is an immediate risk to using Juul products, but "Some of the company’s study findings raised concerns due to insufficient and conflicting data– including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed."

Joe Murillo, chief regulatory officer at Juul Labs, issued a statement saying the company had "provided sufficient information and data based on high-quality research to address all issues raised by the agency" and that the data meets the standard of being "appropriate for the protection of the public health." He added, "We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator."

UPDATE, June 24: Juul asked a federal court in Washington to block the order.

Juul, which has long been blamed for the surge in teen vaping, had already stopped selling its sweet-flavored e-cigarette pods, but had continued selling tobacco- and menthol-flavored cartridges while it waited on the FDA to review its marketing application. The company had also worked on efforts to stop teens from buying its products, like halting television, print and digital advertising. ”

Anti-smoking advocates praised the FDA's ruling. 

Ellen Hahn, a University of Kentucky nursing professor and the director of the Bridging Research Efforts and Advocacy Toward Healthy Environments (BREATHE) initiative, said in an email that the decision "is long overdue. This move is particularly important [for] our ability to breathe in Kentucky. Kentucky youth smoke e-cigarettes, or vapes, over twice the rate of high school students in the U.S. (26.1% vs. 11.3%). E-cigarette aerosol contains highly addictive nicotine that damages the lungs and the developing brain. Vaping is a cause of serious lung injury and makes it harder for the user to fight infection. Lung damage from vaping is comparable to conventional cigarette use." 

That said, Hahn cautioned that since the FDA's decision to limit flavorings in Juul products, other "disposable" vapes have become more popular because they continue to offer a variety of flavors. "So while today’s decision shows the power of FDA’s premarket review, there are plenty of other e-cigarette products still on the market," she said. 

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said the decision "represents the most significant action the FDA has taken to reverse the youth e-cigarette epidemic." 

Harold Wimmer, president and CEO of The American Lung Association, commended the FDA for "following the science and denying Juul the ability to sell its products that are clearly marketed to addict a new generation of youth to tobacco."

Limiting nicotine: The FDA's goal in limiting nicotine in cigarettes and other combusted tobacco products is to reduce youth use, addiction and death, says the FDA news release announcing the effort. 

The FDA notes that while nicotine is not what makes cigarettes so toxic, it is the ingredient that makes it hard to quit. And says if the proposed reduction is successful, it "would make those products minimally- or non-addictive." 

"The U.S. Surgeon General has reported that 87% of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit," Califf said in the release. 

Inside Health Policy reports that the FDA is expected to publish its proposed rule in December. It was originally scheduled for July.